Enhertu, G-tec will benefit from new govn't plan

According to gov't's plan for the compensation of the innovative value of new drugs

Enthertu’s reimb passes pharmacoeconomic évaluations and makes way

New drug G-tec will likely be eligible for preferential drug pricing as a new botanical drug

According to the ‘Plan for the compensation of the innovative value of new drugs’ that the government announced on the 22nd, the breast cancer treatment ‘Enhertu (Daiichi Sankyo-AstraZeneca),’ and the new gastrointestinal botanical drug ‘G-tec (Chong Kund Dang)’ are being regarded as immediate beneficiaries.

 

In the case of Enhertu, it is expected to receive a reimbursement and make way for its reimbursement according to the benefit plan for innovative new drugs according to preferential price awarded to new innovative drugs.' G-tec will receive preferential treatment as a new botanical drug.

 

The burden of drug price cuts for new products produced by innovative pharmaceutical companies will also be reduced based on the eased Price-Volume Agreement system.

 

The government decided to accept reimbursement of innovative new drugs that are recognized by the state.

 

as an innovative new drug, even if they exceed the drug’s ICER threshold, an economic evaluation indicator.

 

The new breast cancer drug Entertu is being evaluated as the only new drug that satisfies the government’s innovativeness standards.

 

The criteria for innovativeness are ▲ there is no substitute or therapeutically equivalent product or treatment ▲ demonstrated clinically meaningful improvement, such as a significant extension in survival ▲ the new drug has been approved by the Ministry of Food and Drug Safety under Article 35(4)(2) of the Pharmaceutical Affairs Act (designation of priority review) and were approved through the fast-track (GIFT) or received a breakthrough therapy designation (BTD) by the US FDA or a priority review (PRIME) by the European Union’s EMA.

 

Enhertu met all of these criteria and is expected be applied a flexible ICER threshold.

 

Enhertu’s reimbursement process is stuck at the pharmacoeconomic evaluation stage because it improved life expectancy and rather increased treatment cost per patient.

 

For example, if the ICER threshold exceeds KRW 50 million, its cost-effectiveness is not recognized, making it difficult to pass the pharmacoeconomic evaluation.

 

However, in this improvement plan, a measure to accept drugs whose innovativeness is recognized, therefore, the drug’s reimbursement progress gains momentum.

 

In addition, Chong Kun Dang’s new drug G-tec will likely benefit and be eligible for preferential drug pricing as a new botanical drug during the reimbursement process.

 

G-tec is a cinnamon bark dried extract that was granted marketing authorization in July last year.

 

The improvement plan reportedly includes preferential drug pricing for drugs developed by innovative pharmaceutical companies.

 

for non-inferior new botanical drugs and new botanical drugs.

 

As a result, there is a possibility that drug prices that were previously set below the weighted average price of alternative drugs or be set in between the highest weighted average price and the weighted average price of alternative drugs.

 

This means that drug prices will be set slightly higher.

 

Chong Kun Dang is an innovative pharmaceutical company, and G-tec is a new botanical drug, so it is likely that the two drugs will both benefit through reimbursement negotiations.

 

On the other hand, Jeil Pharmaceutical’s new Gastroesophageal Reflux Disease (GERD) drug ‘zastaprazan,’ which is considered a potential novel homegrown drug candidate for commercialization next year, is not eligible for this improvement plan.

 

This is because neither Jeil Pharmaceutical nor the drug’s developer, Onconic Therapeutics, is regarded as an innovative pharmaceutical company.

 

Although not immediately eligible, new products from innovative pharmaceutical companies will be able to ease the burden of drug price cuts as they are applied to an eased PVA system.

 

The improvement contains a plan that lowers the drug price cut rate for drugs produced by innovative pharmaceutical companies or an equivalent if the drug is subject to continued PVA price cuts - three times in five years, due to a continuous increase in usage.

 

As a result, products that were subject to more than 3 out of 5 PVA price cuts will receive a reduced price cut rate next year.

 

However, the key is the timing of implementation.

 

The government plans to apply the measures sequentially from the beginning of next year, and the outline of eligible products is expected to be clarified depending on the timing of the revision.

 

An official from the domestic pharmaceutical industry said, "The proposed new drug value compensation plan will at least induce the development of domestically developed drugs, increasing their motivation to develop new drugs.” "This is why domestic pharmaceutical companies have long desired preferential drug pricing for innovative pharmaceutical companies," he said.